Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02145429
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2014-05-20
Brief Title:
Preventing Depression in Late Life A Model for Low and Middle Income Countries
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Preventing Depression in Late Life A Model for Low and Middle Income Countries
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted in GOA India The study addresses specific issues of depression prevention in older adults living in low- and middle income countries LMICs by developing risk-reduction strategies through the use of lay health counselors We will be training Lay Health Counselors LHCs to deliver simple behaviorally oriented interventions designed to enhance the ability to relax to improve active coping via better problem solving and to increase protective factors such as good quality sleep Lay Health Counselors are inhabitants of Goa
The aim of phase 1 is to create a depression and anxiety prevention intervention for use by lay health counselors We will test the feasibility and acceptability of Problem Solving Therapy for Primary Care PST-PC and Brief Behavioral Treatment for Insomnia BBTI The products of phase 1 will be a prevention and counseling manual to standardize the implementation of the interventions for further testing in a randomized prevention trial Specific Aim 2 and the adaptation of PST-PC and BBTI for the Indian population
In Phase 2 we will gather data on the feasibility of identifying enrolling randomizing and retaining participants implement the experimental intervention and enhanced usual care identify real world barriers and develop strategies for addressing them and assess the fidelity of the interventions
The aim of phase 1 is to create a depression and anxiety prevention intervention for use by lay health counselors We will test the feasibility and acceptability of Problem Solving Therapy for Primary Care PST-PC and Brief Behavioral Treatment for Insomnia BBTI The products of phase 1 will be a prevention and counseling manual to standardize the implementation of the interventions for further testing in a randomized prevention trial Specific Aim 2 and the adaptation of PST-PC and BBTI for the Indian population
In Phase 2 we will gather data on the feasibility of identifying enrolling randomizing and retaining participants implement the experimental intervention and enhanced usual care identify real world barriers and develop strategies for addressing them and assess the fidelity of the interventions
Detailed Description:
Prevention of common mental disorders in older adults major depression and anxiety disorders in Low and Middle Income Countries LMICs is a major challenge in global mental health research The public health imperative for devising strategies to prevent late life depression and anxiety in LMICs includes the rapid demographic transition and aging in countries like India increased exposure of older adults to risk factors for depression disability depletion of economic and social resources bereavement care giving and chronic insomnia and workforce issues such as a dearth of mental health specialists The dearth of specialist resources together with the limited ability of current depression treatments to avert years lived with disability underscores the need for preventive interventions that can be delivered by lay health workers in non-health care or primary care settings Such development could also benefit policy and practice in the US by clarifying appropriate roles for lay and non-specialist workers in depression and anxiety prevention for populations with few mental health resources We propose to build upon the MANAS trial conducted in Goa India Given the shortage of mental health specialists in Low and Middle Income Countries LMICs MANAS which means project to promote mental health in the Konkani language employed the strategy of task-shifting that is the rational redistribution of tasks among health workforce teams to make more efficient use of lay human resources for health MANAS demonstrated that the use of lay health counselors LHCs as part of a collaborative stepped care intervention increases rates of recovery from common mental disorders depression and anxiety in public primary care facilities In addition preliminary evidence indicated that the MANAS model of using Lay Health Counselors in a stepped-care collaborative intervention may also reduce the incidence of common mental disorders in those who initially present with subthreshold subsyndromal depressive and anxiety symptoms We propose to investigate translation of depression and anxiety prevention strategies to LMICs through non-specialist delivery systems The goal of this study is to develop and pilot test in Goa India a Lay Health Counselor-led depression and anxiety disorder prevention strategy building upon the experience of the MANAS treatment trial called the DIL Depression in Late Life intervention
Specific Aim 1 formative research months 1 - 12 following Medical Research Council Guidelines for the development of complex interventions we will create and standardize a MANAS-derived depression and anxiety prevention intervention DIL Intervention for use by lay health counselors LHCs in primary care clinics in Goa We will develop an intervention manual based on the original MANAS trial and best practices for depression and anxiety prevention from the global literature Via systematic study of an uncontrolled case series enrolling 20 subjects we will test the feasibility and acceptability of DIL Intervention The DIL Intervention will comprise psychoeducational interventions delivered by Lay Health Counselors and previously shown to have prevention such as Problem Solving Therapy for Primary Care PST-PC and Brief Behavioral Treatment for Insomnia BBTI The products of Specific Aim 1 will be a prevention manual to standardize the implementation of DIL Intervention for further testing in a pilot randomized prevention trial Specific Aim 2 together with recruitment and assessment protocols and a randomization procedure
Specific Aim 2 pilot randomized prevention trial months 13 - 36 Via the use of a pilot randomized prevention trial DIL Intervention we will gather data on the feasibility of identifying enrolling randomizing and retaining participants implement the experimental intervention and enhanced usual care identify real world barriers and develop strategies for addressing them and assess the fidelity of the DIL implementation As recommended in the R34 program announcement PAR-09-173 we will collect measures of feasibility acceptability tolerability and safety rather than conducting formal tests of outcome or attempting to obtain an estimate of an effect size because estimates are likely to be inflated and unstable These data will be critical to a subsequent confirmatory randomized depression prevention trial based in Goa and to our long-term goal of scalable depression prevention in Low and Middle Income Countries LMICs
Specific Aim 1 formative research months 1 - 12 following Medical Research Council Guidelines for the development of complex interventions we will create and standardize a MANAS-derived depression and anxiety prevention intervention DIL Intervention for use by lay health counselors LHCs in primary care clinics in Goa We will develop an intervention manual based on the original MANAS trial and best practices for depression and anxiety prevention from the global literature Via systematic study of an uncontrolled case series enrolling 20 subjects we will test the feasibility and acceptability of DIL Intervention The DIL Intervention will comprise psychoeducational interventions delivered by Lay Health Counselors and previously shown to have prevention such as Problem Solving Therapy for Primary Care PST-PC and Brief Behavioral Treatment for Insomnia BBTI The products of Specific Aim 1 will be a prevention manual to standardize the implementation of DIL Intervention for further testing in a pilot randomized prevention trial Specific Aim 2 together with recruitment and assessment protocols and a randomization procedure
Specific Aim 2 pilot randomized prevention trial months 13 - 36 Via the use of a pilot randomized prevention trial DIL Intervention we will gather data on the feasibility of identifying enrolling randomizing and retaining participants implement the experimental intervention and enhanced usual care identify real world barriers and develop strategies for addressing them and assess the fidelity of the DIL implementation As recommended in the R34 program announcement PAR-09-173 we will collect measures of feasibility acceptability tolerability and safety rather than conducting formal tests of outcome or attempting to obtain an estimate of an effect size because estimates are likely to be inflated and unstable These data will be critical to a subsequent confirmatory randomized depression prevention trial based in Goa and to our long-term goal of scalable depression prevention in Low and Middle Income Countries LMICs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None